Alysena 28 Recalled Product!

Alysena 28

 

Starting date:

April 3, 2013

Posting date:

April 8, 2013

Type of communication:

Drug Recall

Subcategory:

Drugs

Hazard classification:

Type I and II

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-26663

• Reason
• Depth of distribution
• Affected products

Recalled Product

1. Alysena 28

Reason

Packaged product may contain two rows of placebo tablets (14 tablets) and two rows of active contraceptive tablets (14 tablets) in the blister pack. Correct packaging is one row of placebo tablets (7 tablets) and three rows of active contraceptive tablets (21 tablets) in the blister pack.
As per the product monograph, in the case of a missed dose, use a non-hormonal method of contraception as an interim measure until you speak with your physician and obtain medical advice.

Depth of distribution

Wholesalers/distributors and retailers in BC, NB, NF, NS, ON, PE, QC

Affected products

A. Alysena 28

DIN, NPN, DIN-HIM

DIN 02387883

Dosage form

• Tablets

Strength

• 100 mcg levonorgestrel and 20 mcg ethinyl estradiol

Lot or serial number

• LF01899A

Companies

Recalling Firm

Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

Marketing Authorization Holder

Laboratorios Leon Farma S.A.
C/La Vallina s/n Poligono Industrial Navatejera
24008 Villaquilambre, Leon
SPAIN